Bingo Drug-Coated Balloon in Real World | NCT04234893

Studies
Bingo Drug-Coated Balloon in Real World

NCT04234893

Sponsor

Yinyi(Liaoning) Biotech Co., Ltd.

Status

Completed

Last Update Posted

May 27, 2022Actual

Enrollment

805Actual

Phase

Not provided

Conditions

Coronary Stenosis
Drug-coated Balloon
De Novo Stenosis
Coronary Artery Disease in Transplanted Heart Accelerated

Interventions

Not provided

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 3, 2019Actual

Primary Completion Date

Jun 4, 2021Actual

Completion Date

May 4, 2022Actual

First Submitted Date

Jan 6, 2020

First Submission Date that Met QC Criteria

Jan 15, 2020

First Posted Date

Jan 21, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 26, 2022

Last Update Posted Date

May 27, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Conditions Module

Conditions

Coronary Stenosis
Drug-coated Balloon
De Novo Stenosis
Coronary Artery Disease in Transplanted Heart Accelerated

Keywords

Coronary Stenosis
Percutaneous Coronary Intervention
Drug-coated Balloon
Drug eluting Balloon
Paclitaxel
De novo
Bifurcation
Coronary Artery Disease

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

2 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

805Actual

Label	Type	Description	Intervention Names
Drug-coated balloon		The Patients who treated with Bingo drug-coated balloon

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Major Adverse Cardiovascular Events	a composite endpoint of cardiovascular death, myocardial infarction, clinical driven target lesion revascularization	12 months

Secondary Outcomes

Measure	Description	Time Frame
device success	study device successfully dilate in the lesion without using bail-out stent	immediately after the procedure
lesion success	residual diameter stenosis ≤30% and the TIMI flow grade 3 of the target lesion

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Age 18 or older, regardless of gender;
Patients suitable for PCI with paclitaxel drug-coated balloon;
Patients able to understand the purpose of this study, provide an informed consent and cooperate with clinical follow-up.

Exclusion Criteria:

General exclusion criteria

Contraindications to PCI;
In-stent restenosis;
Life expectation less than 1 year;
Patients not suitable for enrollment considered by investigator.

Angiographic exclusion criteria:

1. Target lesion with the following conditions after pre-dilatation:

Residual stenosis larger than 30% ;
TIMI flow grade less than 3;
Type C-F dissection (NHLBI grade).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

PCI with Bingo drug-coated balloon

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Jian-an Wang, MD, PhD	Second Affiliated Hospital, School of Medicine, Zhejiang University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
The Second Affiliated hospital of Zhejiang University School of Medicine		Hangzhou	Zhejiang	310009	China

Condition Browse Module

MeSH Terms

ID	Term
D023921	Coronary Stenosis
D003324	Coronary Artery Disease

Ancestor Terms

ID	Term
D003327	Coronary Disease
D017202	Myocardial Ischemia
D006331	Heart Diseases
D002318	Cardiovascular Diseases

Browse Leaves

Not provided

Browse Branches

Not provided